Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 36301–36320 of 38,428 recalls

February 4, 2013· Hospira Inc.

Recalled Item: Symbiq Two Channel Infuser

The Issue: Symbiq Infusers have the potential to experience a

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 4, 2013· Hospira Inc.

Recalled Item: Symbiq One Channel Infuser

The Issue: Symbiq Infusers have the potential to experience a

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 4, 2013· Hospira Inc.

Recalled Item: Symbiq One Channel Infuser

The Issue: Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 4, 2013· Hospira Inc.

Recalled Item: Symbiq Two Channel Infuser

The Issue: Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 4, 2013· Arrow International Inc

Recalled Item: The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep

The Issue: The tunneling sheath packaged within the kits can

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 4, 2013· SpineNet

Recalled Item: SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac

The Issue: SpineNet was marketing this device to be used

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 4, 2013· Hospira Inc.

Recalled Item: The Hospira Symbiq Infusion System is intended for the delivery of fluids

The Issue: The devices secondary audio signal fails to activate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 4, 2013· Endogastric Solutions Inc

Recalled Item: EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories

The Issue: EsophyX2Plus device was not validated under actual or

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 4, 2013· Genetic Testing Institute,inc

Recalled Item: Gen-Probe LIFECODES PF4 Enhanced assay

The Issue: Lifecodes PF4 Enhanced assay, lot number 3000389, is

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 4, 2013· Ultradent Products, Inc.

Recalled Item: Ultradent Products

The Issue: Incorrect packaging of regular set and fast set

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskTerminated
February 4, 2013· Ultradent Products, Inc.

Recalled Item: Ultradent Products

The Issue: Incorrect packaging of regular set and fast set

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskTerminated
February 1, 2013· ICU

Recalled Item: The Plum A+ Infusion Systems are a multipurpose family of

The Issue: A possible interruption of therapy when an E321

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 1, 2013· ICU

Recalled Item: The Plum A+ Infusion Systems are a multipurpose family of

The Issue: A possible interruption of therapy when an E321

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 1, 2013· ICU

Recalled Item: The Plum A+ Infusion Systems are a multipurpose family of

The Issue: A possible interruption of therapy when an E321

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 1, 2013· ICU

Recalled Item: The Plum A+ Infusion Systems are a multipurpose family of

The Issue: A possible interruption of therapy when an E321

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 1, 2013· ICU

Recalled Item: The Plum A+ Infusion Systems are a multipurpose family of

The Issue: A possible interruption of therapy when an E321

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 1, 2013· ICU

Recalled Item: The Plum A+ Infusion Systems are a multipurpose family of

The Issue: A possible interruption of therapy when an E321

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 1, 2013· ICU

Recalled Item: The Plum A+ Infusion Systems are a multipurpose family of

The Issue: A possible interruption of therapy when an E321

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 1, 2013· ICU

Recalled Item: The Plum A+ Infusion Systems are a multipurpose family of

The Issue: A possible interruption of therapy when an E321

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
February 1, 2013· ICU

Recalled Item: The Plum A+ Infusion Systems are a multipurpose family of

The Issue: A possible interruption of therapy when an E321

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated